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Trial record 45 of 534 for:    ESCITALOPRAM AND Disorders

Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01997580
Recruitment Status : Unknown
Verified November 2013 by Jae Seung Chang, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : November 28, 2013
Last Update Posted : November 28, 2013
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Jae Seung Chang, Seoul National University Bundang Hospital

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE November 28, 2013
Last Update Posted Date November 28, 2013
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz) [ Time Frame: 0, 3, 7, 14, and 42 days ]
the link between the normalized high frequency component of heart rate variability (HRV-HFnu) representing cardiac vagal modulation and frontal alpha power related to resting state
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
  • Change in cardiorespiratory coupling during 6 weeks [ Time Frame: 0, 3, 7, 14, and 42 days ]
    change in value of cross-sample entropy measured by combining sample entropies of heart rate and respiration
  • Change in HF during 6 weeks [ Time Frame: 0, 3, 7, 14, and 42 days ]
    change in high frequency component of heart rate variability
  • Change in persistent homology during 6 weeks [ Time Frame: 0, 3, 7, 14, and 42 days ]
    change in disconnection pattern of EEG channel activities measured by Euclidean distance during 6 weeks
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder
Official Title  ICMJE Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
Brief Summary To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder
Detailed Description Case-control study Repeated measures design
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE Drug: escitalopram
SSRI antidepressant
Other Name: lexapro
Study Arms  ICMJE
  • Experimental: Escitalopram
    depressed patients receiving escitalopram treatment
    Intervention: Drug: escitalopram
  • No Intervention: Control
    healthy controls matched for age, gender, and BMI
Publications * Chang JS, Yoo CS, Yi SH, Her JY, Choi HM, Ha TH, Park T, Ha K. An integrative assessment of the psychophysiologic alterations in young women with recurrent major depressive disorder. Psychosom Med. 2012 Jun;74(5):495-500. doi: 10.1097/PSY.0b013e31824d0da0. Epub 2012 Mar 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 22, 2013)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • DSM-IV-TR major depressive disorder
  • aged between 20 and 80
  • durg-naive or drug-free

Exclusion Criteria:

  • DSM-IV-TR substance-related disorders (except nicotine)
  • significant medical or neurological conditions
  • mental retardation or organic brain damage
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01997580
Other Study ID Numbers  ICMJE A121987
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jae Seung Chang, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Ministry of Health & Welfare, Korea
Investigators  ICMJE
Principal Investigator: Jae Seung Chang, MD, PhD Seoul National University Bundang Hospital
PRS Account Seoul National University Bundang Hospital
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP